This invention is in the field of naso-gastric tubes or stomach tubes, which are commonly used devices during and following surgery. This type of tube is typically made of clear or tinted plastic having proximal and distal ends, a central bore and additional apertures near the distal end. In use the distal end is inserted upward into a patient's nostril or mouth; then it is pushed along a path past the nasal pharynx, then downward past the oral pharynx, and finally downward through the esophagus into the stomach. At the proximal end a suction pump is connected for drainage of gastric secretions, particularly when a patient is being fed intravenously. These tubes or catheters typically remain in place from several hours to two weeks depending on the patient's condition, this device and procedure being essentially unchanged in approximately forty years. Of course there have been developed improved plastic materials which produce tubes which are stronger, smoother, self-lubricating, have x-ray opaque markings for fluoroscopic location during and after insertion, and are designed to reduce clogging.
These tubes, now made by more than one dozen manufacturers, are generally successful for their primary purpose, namely reliable drainage. However, there are numerous unpleasant, uncomfortable and sometimes dangerous ancillary effects associated with the use of these tubes or catheters, certain of these negative aspects being so familiar to surgeons and nursing staff that they have become accepted as inherent parts of procedures which require the use of naso-gastric tubes. There are two different types of problems with which we are presently concerned: (a) actual irritation, necrosis and/or ulceration of tissue associated with the nostril, pharynx, and esophagus, and (b) painful discomfort to these areas, often becoming sheer misery for the patients who must experience an indwelling naso-gastric tube or catheter during their stay in a hospital.
Certain of the problems and discomfort described above are inherent in the procedure of inserting and maintaining a naso-gastric tube in a patient's nostril; however, thereafter these problems can become aggravated by (a) bending and twisting of the otherwise stationary indwelling tube, (b) by gross movement of the tube or the patient relative to the tube, and (c) by the well-known and standard technique of using layers of adhesive tape to secure the exposed portion of the tube to the patient's upper lip or nose and cheek. Bending and twisting of the indwelling tube occurs because the downward extending exposed portion of the tube near the upper lip is bent and the tube is redirected upward past the cheek and thence to a suction apparatus. While the tube feels somewhat soft, this is misleading. In reality the tube has considerable stiffness so that it will not collapse inwardly due to the suction, and will not collapse or bend transverse to its axis while it is being pushed axially during insertion about numerous and reverse curves of the internal passageways. Thus the tube has considerable hardness and any portion of the tube bearing against tissue can lead to great pain.
Another important but subtle problem is the reaction force set up by bending this "apparently soft" tube as it exits the nostril. The edge of the nostril or other point of contact by the tube becomes a fulcrum or pivot point contacted by an intermediate portion of the tube between a lower exposed portion of the tube which is bent or pulled, and an upper indwelling portion. Specifically, if the lower part is pulled to the right, the intermediate portion remains in contact where it was, and the inward portion tends to move to the left and produce a reaction force to the left against adjacent tissue. It has been determined that this reaction force may be quite substantial.
The second of three above-listed aggravating factors in causing pain and necrosis is gross movement of the tube or the patient, as contrasted with bending and twisting a stationary tube. The tube extending out of a nostril can be moved or even yanked when the patient moves in certain improper ways, or when the sheet or other apparatus to which the tube is attached is improperly moved, or even from coughing or swallowing by the patient, with a result of severe pain in the nostril and adjacent areas.
The use of adhesive tape to reduce tube movement is only partially successful for that purpose, and such tape creates new and sometimes worse problems. The tape itself is unpleasant in that it pulls the skin constantly, is particularly uncomfortable in hot, humid conditions, and is painful to remove from the skin. Removal of the tape from the tube, when necessary, causes additional movement of the tube and associated pain. Another particularly unfortunate feature of using adhesive tape is that the tape typically holds the tube closely and tightly against the upper lip or philtrum; however, the natural direction of the tube upon exiting the nose is outward, away from the upper lip surface, and this act of adhering the tube to that surface is effectively bending the tube and causing a reaction force against other tissue upward in the nostril, as described earlier. The prior art use of additional adhesive tape to hold a portion of the naso-gastric tube tightly against the patient's cheek, leads to further pulling of the skin and bending the tube into an unnatural curvature with associated reaction forces.
Certain devices have been proposed in the prior art which engage an exposed portion of a naso-gastric tube by means of adhesive or elastic tape, or use of a sleeve or collar about the tube, while the device is secured to the head by separate tape or a harness encircling the head. This use of tape in prior devices is now considered undesirable because of the time and nuisance to secure and release the tape and the loss of effectiveness when the tape becomes wet; any requirement for wrapping elastic around the tube or sliding a collar along the length of the tube extending out of the patient's nostril either causes pain which the present invention seeks to avoid, or is too clumsy and impractical to be taken seriously. In one case a spectacle-type frame was proposed which included a clip on one temple for engaging a portion of the nasal catheter, but made no effort to align the tube properly or to prevent movement of the tube in the vicinity of the nostril. In still another unsuccessful attempt to truly solve the problems described above, an adhesive-backed VELCRO patch was adhered to the patient's cheek, and a collar with a VELCRO outer surface is secured on the tube. When pressed together the mating VELCRO surfaces will releasably adhere together; however emplacement of the collar on the tube is impractical, and the use of adhesive on the face is a procedure the present invention successfully avoids. A still further attempt to solve the above-described problems involved a device which engaged and aligned the exposed portion of a naso-gastric tube by means of slots and grooves; however, in order for the device to have sufficient strength and resilience to securely but releasably grip the tube without additional holding means, the device was made of semi-rigid material and therefore was relatively hard, and when pressed against the patient's upper lip during use, produced its own discomfort.
In reviewing all the known prior art, none of the devices solve all the problems inherent with naso-gastric tubes and inherent with the devices themselves intended to releasably locate and secure these tubes. The present invention is a device and technique which finally combine structural features to align and securely and releasably grip the tube with ease and speed, while vastly reducing patient discomfort without introducing new discomfort. More particularly, this new invention successfully reduces irritation necrosis, ulceration and pain caused by indwelling naso-gastric and related tubes, as is summarized below, followed by a detailed description of preferred embodiments of the new concept.